BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIX WIN PRO

    K Number: K060178 · Decision Mar 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    46

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VIX WIN PRO
    K Number
    K060178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gendex Dental Systems
    Date Received
    January 23, 2006
    Decision Date
    March 10, 2006
    Product Code
    MUH
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUH System, X-Ray, Extraoral Source, Digital

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MUH), ordered by most recent decision date.

    SOTA Cloud Smart Sensor (1.5)

    FDA 510(k)
    FDA Class 2 ·Dental

    EzSensor HD, EzSensor UHD

    FDA 510(k)
    FDA Class 2 ·Dental

    Cocoon Solo (DX-7020s)

    FDA 510(k)
    FDA Class 2 ·Dental

    Digital X-Ray DentiMax Pro Imaging System

    FDA 510(k)
    FDA Class 2 ·Dental

    VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)

    FDA 510(k)
    FDA Class 2 ·Dental

    X Sensor (Model: IOS-A15IF, HDI-15DGF)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Gendex Dental Systems

    K Number Device Name
    K050255 ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4